OvertureTi PKG-90-OVR-300020Recalls & reported problems
Overture Orthopaedics · Class 2 · Implant
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810129550207), received between Nov 14, 2025 and Feb 13, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Naturally Worn” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn2
- Material Fragmentation1
Patient problems
- Arthralgia1
- Swelling/ Edema1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 13, 2026Naturally Worn
A BIPOLAR OVERTURE IMPLANT WAS REVISED TO A UKA ON (B)(6) 2026. REVISION WAS INDICATED BECAUSE OF PERSISTENT SWELLING. INSPECTION OF THE WELL-FIXED TIBIAL COMPONENT DEMONSTRATED EVIDENCE OF SIGNIFICANT POLYETHYLENE WEAR ON THE MEDIAL SIDE.
Patient problems: Swelling/ Edema
MAUDE report 24338139 ↗InjuryNov 14, 2025Material Fragmentation; Naturally Worn; Material Fragmentation; Naturally Worn
ON OCTOBER 14, 2025, OVERTURE WAS NOTIFIED OF A REVISION SURGERY INVOLVING THE REMOVAL OF TIBIAL 20MM AND FEMORAL OBLONG 22.5X40MM IMPLANTS, INITIALLY IMPLANTED ON (B)(6) 2024. THE REVISION WAS PERFORMED TO CONVERT THE OVERTURE SYSTEM TO A TOTAL KNEE REPLACEMENT AFTER THE PATIENT REPORTED KNEE PAIN. THE SURGEON STATED THAT THE IMPLANTS WERE WELL FIXED, BUT THERE WERE POLY FRAGMENTS IN THE KNEE. THE TIBIAL POLYETHYLENE ARTICULATION SURFACE WAS WORN AND PITTED. THE FEMORAL COMPONENT APPEARED UNREMARKABLE.
Patient problems: Arthralgia
MAUDE report 23555600 ↗
Other Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer devices
- LinkSymphoKnee 880-307/21WALDEMAR LINK GmbH & Co. KG · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls2 reports
- Scorpio 73-3710Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls1 report
- Scorpio 73-3110Howmedica Osteonics Corp. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER2 recalls0 reports
- Arthrex® AR-503-TTTEArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall14 reports
- Arthrex® AR-503-TTTJArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall9 reports
- ENGAGE 1-10011-300Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- Arthrex® AR-503-TTTGArthrex, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall7 reports
- ENGAGE 1-10003-400Smith & Nephew, Inc. · PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER1 recall6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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